A Randomised, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy and Safety of Zoria Cream in the Treatment of Mild to Moderate Chronic Plaque Psoriasis
- Conditions
- This study will be conducted on adult participants aged 20 years and above, diagnosed with mild to moderate Chronic Plaque Psoriasis.Chronic Plaque Psoriasis, Modified PASI, Zoria Cream, ESI score
- Registration Number
- TCTR20240330004
- Lead Sponsor
- Pan Rajdhevee Group Public Co. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 24
1. Healthy participant of the age of 20 years old or above, 2. Participant diagnosed with mild to moderate Chronic Plaque Psoriasis with less than 10% of body surface area involved, 3. Participant must give informed consent prior to study enrolment and all study procedures, 4. Participant must be able to comply with study procedures and be available for all study visits, 5. Participant must be in general good health based on medical history as determined by the investigator(s) at Screening.
1. Participants not diagnosed with mild to moderate Chronic Plaque Psoriasis with less than 10 percent of body surface area involved, 2. Participants with signs of excoriation at the psoriatic lesion e.g., excoriated skin, scab, scratches, or broken skin associated with their plaques, 3. Participants diagnosed with other inflammatory diseases, 4. Participants who have previously used topical and systemic treatments for their psoriasis within 4 weeks prior to Screening and Enrolment (Day 1), 5. Participants who have previously used phototherapy, immunomodulatory therapy, or any other medicines known to influence psoriasis within 12 weeks prior to Screening and Enrolment (Day 1), 6. Participants with the presence of self-reported or medically documented significant medical or psychiatric condition(s) as judged by the investigator(s) that it may not be in the participants interest to participate in the study, 7. Participants with a history of severe allergy (requiring hospital care), anaphylaxis, severe reaction to any drug, or any known or suspected allergies or sensitivities to any component of the Study Drug or Placebo, 8. Participants with a history of alcohol or drug abuse that, in the opinion of the PI(s), could affect the participant safety or compliance with study, 9. Participants with the presence of an acute illness, as determined by the PI(s), with or without fever (forehead temperature measured with validated device more than equal 37.5 degree Celsius) at Screening and Enrolment (Day 1), 10. Use of any other therapeutic or cosmetic products, devices or procedures that could interfere with the assessments of the treatment areas within 7 days prior to Screening and Enrolment (Day 1), unless approved by the PI(s), 11. Participants who are currently participating in any other interventional clinical trial or previously enrolled in an interventional clinical trial, which in the opinion of the PI(s) may interfere with the interpretation of the trial results, 12. Participants with a close affiliation with the PI(s), person working at the trial site(s) or an employee of the sponsor (e.g., a close relative).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plaque Psoriasis Lesions area at 8 weeks after received intervention Plaque Psoriasis area
- Secondary Outcome Measures
Name Time Method Severity of Plaque Psoriasis lesion at 8, 24 weeks after received intervention ESI score,Plaque Psoriasis Clearance at 24 weeks after received intervention Absence of an indurated plaque,Safety Day 1 - Week 24 The number and percentage of Adverse Events (AEs),Keratin of the epidermis at 24 weeks after received intervention Smooth and Soft Skin (SSS) Test